PRINCETON, N.J. — Promius Pharma LLC has received Food and Drug Administration approval for Sernivo Spray 0.05%, a psoriasis medication.
A prescription topical steroid, Sernivo Spray (betamethasone dipropionate 0.05%) is indicated for the treatment of mild to moderate plaque psoriasis in adult patients, according to Promius, the U.S. subsidiary of India-based Dr. Reddy’s Laboratories.
“The FDA approval of Sernivo Spray is a significant milestone for Promius, as it validates our committed efforts and resources to developing differentiated dermatology products from concept to commercial launch,” stated G.V. Prasad, co-chairman and chief executive officer of Dr. Reddy’s. “We are delighted to receive a first-round FDA approval of Sernivo Spray as we look to expand our portfolio of medical dermatology products available in the U.S. market.”
Promius said the commercial launch of Sernivo Spray is planned for the coming quarter.
“As an emerging leader in the dermatology space, we are committed to developing innovative treatment options and support services for clinicians and patients,” commented Promius president Raghav Chari, who’s also executive vice president of proprietary products at Dr. Reddy’s. “The approval of Sernivo emphasizes our ongoing efforts, and we look forward to a successful launch of Sernivo Spray in the coming quarter.”